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Implanted Stimulator a ‘Paradigm Shift’ for Low Back Pain?
A safe and minimally invasive implanted stimulation device is getting mostly positive reviews from neurosurgeons, with some experts saying it represents a “paradigm shift” in the treatment of mechanical low back pain.
Results from a multicountry study show that the ReActiv8 device (Mainstay Medical Limited) is efficacious, improving function and reducing pain for up to 2 years for patients with back pain caused by loss of function in the multifidus muscle.
“We’re really getting a muscle that wasn’t going to fire again,” co-investigator Chris Gilligan, MD, chief of the Division of Pain Medicine, Brigham and Women’s Hospital, Boston, Massachusetts, told Medscape Medical News.
The intervention represents the first restorative neurostimulation for back pain, Gilligan said. Conventional spinal cord devices stimulate sensory nerves and merely cover up pain, he noted.
“This isn’t covering up pain. This is restoring function of the strongest stabilizing muscle of the lumbar spine and in that way returning neuromuscular control and stability such that the patient’s pain improves,” Gilligan said.
The findings were discussed at the American Association of Neurological Surgeons (AANS) 2021 Annual Meeting, which was held online.
“Like a Pleasant Massage”
Patients with chronic neuropathic low back pain may be candidates for surgical procedures, such as fusion or decompression. However, these are not options for the larger population of individuals with nociceptive mechanical pain, many of whom have dysfunction of the multifidus muscle.
The current study included 204 relatively young patients (mean age, 47 years) who were enrolled at 26 sites around the world, including 16 sites in the United States. Baseline score on a low back pain visual analogue scale (VAS) was 7.3 cm, and the baseline Oswestry Disability Index (ODI) score was 39 points.
Participants had had low back pain for about 14 years and had experienced pain on 97% of days in the prior year. Virtually 100% had previously undergone physical therapy without success.
For all patients, pain medication had failed: 37% were taking opioids at the start of the study, and interventional pain therapies, such as steroid injections, had failed for 52% of the patients.
The participants were randomly assigned either to the therapeutic stimulation group or to a sham stimulation group.
FDA Approval
On the basis of these results, the US Food and Drug Administration (FDA) approved the device last year, as reported by Medscape Medical News at the time.
For 156 patients, their condition continued to improve at 2 years, said Gilligan. “The longer you treat, the greater the benefits,” he said.
Some patients found they needed less and less stimulation, to the point where the implant was removed. Others continue to regularly use the stimulator. One patient in Australia has had it for 7 years, Gilligan reported.
During the sponsored session featuring the research, Robert M. Levy, MD, PhD, president of the International Neurostimulation Society, said the stimulator should “have a great impact” because neurosurgeons have had little to recommend to back pain patients who are not good candidates for a spinal operation.
“For the very first time, there is a minimally invasive, safe, and yet highly effective procedure to offer these patients,” Levy said.
Other session speakers agreed that the device represents “a paradigm shift” in treating such patients.
American Association of Neurological Surgeons (AANS) 2021 Annual Meeting. Lunch and Learn Session, August 23, 2021.
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